Actively Recruiting
Study of VARIPULSE Catheter and TRUPULSE Generator with VARIPULSE Pro Software for Treating Persistent Atrial Fibrillation in Adults
Led by Biosense Webster, Inc. · Updated on 2026-07-07
50
Participants Needed
10
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of the pulsed field ablation PFA system, which includes the VARIPULSE catheter, TRUPULSE generator, and the new VARIPULSE Pro software, for treating participants with persistent atrial fibrillation PsAF. This condition involves an irregular, rapid heart rhythm lasting more than 7 days that does not stop on its own. The study aims to investigate the clinical workflow and effectiveness of this system during cardiac ablation procedures for PsAF. Participants selected for this study will undergo pulmonary vein isolation using the pulsed field ablation system with the specified devices and software. The ablation procedure is intended to manage symptomatic persistent atrial fibrillation, especially in those who have failed at least one antiarrhythmic drug. The study does not include a comparison group and focuses on a single group receiving the PFA treatment. During the study, participants will be monitored for several outcomes including acute procedural success during the ablation, durability of pulmonary vein isolation up to 3 months, and details such as the time and number of pulsed field applications. Safety assessments include monitoring serious and non-serious adverse events, neurological status through scales like the Mini Mental State Examination and NIH Stroke Scale, and MRI evaluations for cerebral emboli. Follow-up and testing will occur before, during, and up to 3 months after the ablation procedure, with the overall participation lasting several months.
CONDITIONS
Brief Title
A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE PRO Software in Participants With PsAF
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with symptomatic persistent atrial fibrillation (PsAF)
- Selected to undergo ablation procedure for management of arrhythmia by pulmonary vein isolation
- Failed at least one antiarrhythmic drug (class I to IV) due to recurrent symptoms or intolerance
- Aged 18 to 75 years
- Willing and able to provide consent
- Able and willing to comply with all pre-, post-, and follow-up testing and requirements
You will not qualify if you...
- Continuous atrial fibrillation longer than 12 months (longstanding persistent AF)
- Previous surgical or catheter ablation for atrial fibrillation
- Cardiac surgery or percutaneous coronary intervention within 2 months prior to consent
- Previous coronary artery bypass grafting with valvular or cardiac surgery
- History of carotid stenting or endarterectomy
- Presence of left atrial thrombus
- Severe left atrial enlargement (diameter > 50 mm)
- Severely reduced left ventricular ejection fraction (< 40%)
- Significant pulmonary vein anomaly preventing study enrollment
- Prior pulmonary vein stenosis diagnosis
- Pre-existing hemidiaphragmatic paralysis
- History of blood clotting or bleeding disorders or contraindication to anticoagulants
- Myocardial infarction within 2 months prior to consent
- Thromboembolic events within 6 months prior to consent
- Rheumatic heart disease
- Uncontrolled heart failure or NYHA class III or IV
- Severe mitral regurgitation
- Planned cardiac transplantation or major surgery within 12 months
- Unstable angina within 6 months prior to consent
- Acute illness, systemic infection, or sepsis
- Atrial fibrillation secondary to reversible or non-cardiac causes
- Structural heart abnormalities preventing catheter use
- Significant pulmonary or respiratory disease causing chronic symptoms
- Significant congenital anomalies or medical problems precluding enrollment
- Women who are pregnant, lactating, or planning pregnancy during study
- Current participation in another investigational device, biologic, or drug study
- Contraindications for study devices per instructions for use
- Vulnerable populations requiring special protections
- Life expectancy less than 12 months
- Contraindications for MRI or presence of metal fragments
- Unresolved pre-existing neurological deficits
Research Team
W
Wannes Vermander
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